[29H,31H-phthalocyaninato(2-)-kappa4N29,N30,N31,N32]copper, sulfonated, condensed with 2,4- diaminobenzenesulfonic acid and ammonia, converted with sodium hydroxide 2,4,6-trichloro-1,3,5-triazine and ammonium chloride

Acute Toxicity: oral

Administrative data

Endpoint:

acute toxicity: oral

Type of information:

experimental study

Adequacy of study:

key study

Study period:

1987

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

comparable to guideline study with acceptable restrictions

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

1987

Report date:

1987

Materials and methods

Test guideline

Qualifier:

equivalent or similar to guideline

Guideline:

OECD Guideline 401 (Acute Oral Toxicity)

GLP compliance:

not specified

Test type:

standard acute method

Limit test:

no

Test material

Test material information

Constituent 1

Reference substance name:

Reaction products of [29H,31H-phthalocyaninato(2-)-k4N29,N30,N31,N32]copper, thionyl dichloride, and sulfurochloridic acid, further condensed with 2,4-diaminobenzenesulfonic acid and ammonia, further converted with sodium hydroxide 2,4,6-trichloro-1,3, -triazine, and ammonium chloride

EC Number:

942-002-2

Molecular formula:

C42.53H20.97Cl1.17N15.41Na3.62O13.95S5.17

IUPAC Name:

Reaction products of [29H,31H-phthalocyaninato(2-)-k4N29,N30,N31,N32]copper, thionyl dichloride, and sulfurochloridic acid, further condensed with 2,4-diaminobenzenesulfonic acid and ammonia, further converted with sodium hydroxide 2,4,6-trichloro-1,3, -triazine, and ammonium chloride

Test material form:

solid: particulate/powder

Remarks:

powder

Specific details on test material used for the study:

Test substance: FAT 400045/C
Batch No.: EN 19609.62

Test animals

Species:

rat

Strain:

other: albino

Sex:

male/female

Details on test animals or test system and environmental conditions:

not available

Administration / exposure

Route of administration:

oral: gavage

Vehicle:

not specified

Details on oral exposure:

no data

Doses:

2000 and 5000 mg/kg bw

No. of animals per sex per dose:

3

Control animals:

not specified

Statistics:

no data

Results and discussion

Effect levels

Sex:

male/female

Dose descriptor:

approximate LD50

Effect level:

> 5 000 mg/kg bw

Based on:

test mat.

Mortality:

No mortality occurred at the dose of 2000 mg/kg bw. In the rats administered 5000 mg/kg bw, 1/3 males and 1/3 females were found dead during the observation period.

Clinical signs:

other: Dyspnoea, exophthalmos, ruffled fur, and curved body position were seen, being common symptoms in acute toxicity testing. The surviving animals recovered within 10-12 d.

Gross pathology:

At autopsy, no deviations from normal morphology were found in the animals of the 2000 mg/kg bw dose group. The gastrointestinal tract was dilated in the male and the female of the 5000 mg/kg bw dose group which died on day 1.

Other findings:

no data

Applicant's summary and conclusion

Interpretation of results:

GHS criteria not met

Conclusions:

The oral LD50 of the test substance was >5000 mg/kg bw in rats.

Executive summary:

A study was conducted to assess the acute oral toxicity of the test substance in albino rats following a method comparable to OECD Guideline 401. Two groups of rats (3/sex/dose) received a single oral (gavage) dose of either 2000 or 5000 mg/kg bw of the test substance. No mortality occurred at 2000 mg/kg bw. However, in the rats administered 5000 mg/kg bw, 1/3 males and 1/3 females were found dead during the observation period. Dyspnoea, exophthalmos, ruffled fur and curved body position, being common symptoms in acute toxicity studies, were seen in treated animals. Surviving animals recovered within 10-12 d. At autopsy, no deviations from normal morphology were found at 2000 mg/kg bw. The gastrointestinal tract was dilated in the male and the female of the 5000 mg/kg bw dose group which died on Day 1. Based on these findings, the approximate oral LD50 of the test substance was considered to be >5000 mg/kg bw in rats.